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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

Current Report

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): January 13, 2020

 

ADAPTIMMUNE THERAPEUTICS PLC

(Exact name of registrant as specified in its charter)

 

England and Wales   1-37368   Not Applicable
(State or other jurisdiction of
incorporation)
  (Commission File Number)   (IRS Employer Identification No.)

 

60 Jubilee Avenue, Milton Park

Abingdon, Oxfordshire OX14 4RX

United Kingdom

(Address of principal executive offices, including zip code)

 

(44) 1235 430000

(Registrant’s telephone number, including area code)

  

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: 

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol   Name of each exchange on which
registered
American Depositary Shares, each representing 6 Ordinary Shares, par value £0.001 per share   ADAP   The Nasdaq Global Select Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company ¨

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

 

 

 

 

Item 7.01 Regulation FD Disclosure.

 

On January 13, 2020, Adaptimmune Therapeutics plc (the “Company”) issued a press release announcing that its SPEAR T-cell platform has delivered initial responses in four solid tumor indications. The Company reported two confirmed Partial Responses (PRs) – one in a patient with liver cancer and one in a patient with melanoma, and two unconfirmed PRs – one in a patient with gastro-esophageal junction cancer and one in a patient with head and neck cancer. The press release is furnished as Exhibit 99.1 and is incorporated by reference herein.

 

The information contained in Item 7.01 of this Form 8-K, including Exhibit 99.1 furnished herewith, shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by the Company by specific reference in such a filing.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.   Description of Exhibit
     
99.1   Press release dated January 13, 2020
     
104   Cover Page Interactive Date File (embedded within the Inline XBRL document)

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.

 

 

 

ADAPTIMMUNE THERAPEUTICS PLC

     
     
Date: January 13, 2020 By: /s/ Margaret Henry
    Name: Margaret Henry
    Title:      Corporate Secretary

 

 

Exhibit 99.1

 

     

 

Adaptimmune Announces that SPEAR T-cell Platform Delivers Initial Responses in Four Solid Tumor Indications

 

- Partial Responses seen in liver, melanoma, gastro-esophageal junction, and head and neck cancers -

 

- Encouraging demonstration of the potential of SPEAR T-cell platform across multiple targets and a range of solid tumors -

 

PHILADELPHIA, PA., and OXFORDSHIRE, United Kingdom, January 13, 2020 -- Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in cell therapy to treat cancer, reported today, at the 38th JP Morgan Healthcare Conference, two confirmed Partial Responses (PRs) – one in a patient with liver cancer and one in a patient with melanoma. There are also two unconfirmed PRs – one in a patient with gastro-esophageal junction cancer and one in a patient with head and neck cancer. These data further confirm the potential of Adaptimmune’s SPEAR T-cell platform for patients with multiple solid tumors. Data were previously reported showing compelling efficacy with ADP-A2M4 in synovial sarcoma.

 

“These responses demonstrate that our proprietary SPEAR T-cell platform is clearly active and can overcome the challenges of treating a range of solid tumors with a T-cell therapy product,” said Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer. “These are early results and we need more patient data and durability information to determine which therapies to develop. Nonetheless, this is a critical demonstration of the value of our SPEAR T-cell therapies for people with cancer and a validation of the importance of our proprietary affinity engineering. I couldn’t be prouder of the team at Adaptimmune, and we are grateful to the investigators and patients who have put their faith in our treatment. We look forward to presenting data from these trials at future scientific congresses.”

 

Best overall responses:

· A confirmed PR (decrease of 100% in target lesions) in a patient with hepatocellular carcinoma (liver cancer) – the first patient treated in the third cohort of the Phase 1 ADP-A2AFP trial
· A confirmed PR (decrease of 42% in target lesions) in a patient with metastatic rectal mucosal melanoma – the first patient treated in the low-dose radiation sub-study of the Phase 1 ADP-A2M4 trial
· An unconfirmed PR (decrease of 42% in target lesions) in a patient with metastatic gastro-esophageal junction cancer – the first patient treated in the first cohort of the next-generation SURPASS trial
· An unconfirmed PR (decrease of 36% in target lesions) in a patient with head and neck cancer treated in the expansion phase of the Phase 1 ADP A2M4 trial

 

There continues to be a favorable benefit:risk profile for all products and indications under study. Most adverse events are consistent with those typically experienced by cancer patients undergoing cytotoxic chemotherapy or other cancer immunotherapies. Adverse events (including cytokine release syndrome, neurotoxicity, and prolonged cytopenias) occur at rates consistent with other T-cell therapies, and are managed in keeping with current guidelines.

 

About Adaptimmune

Adaptimmune is a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapy products for people with cancer. The Company’s unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors. For more information, please visit http://www.adaptimmune.com.

 

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Adaptimmune Forward-Looking Statements

This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA). These forward-looking statements involve certain risks and uncertainties. Such risks and uncertainties could cause our actual results to differ materially from those indicated by such forward-looking statements, and include, without limitation: the success, cost and timing of our product development activities and clinical trials and our ability to successfully advance our TCR therapeutic candidates through the regulatory and commercialization processes. For a further description of the risks and uncertainties that could cause our actual results to differ materially from those expressed in these forward-looking statements, as well as risks relating to our business in general, we refer you to our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 6, 2019, and our other SEC filings. The forward-looking statements contained in this press release speak only as of the date the statements were made and we do not undertake any obligation to update such forward-looking statements to reflect subsequent events or circumstances.

 

Adaptimmune Contacts:

 

Media Relations:

Sébastien Desprez – VP, Communications and Investor Relations

T: +44 1235 430 583

M: +44 7718 453 176

Sebastien.Desprez@adaptimmune.com

 

Investor Relations:

Juli P. Miller, Ph.D. – Senior Director, Investor Relations

T: +1 215 825 9310

M: +1 215 460 8920

Juli.Miller@adaptimmune.com

 

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